Intervention With Tralokinumab in Patients With Moderate-to-severe Atopic Dermatitis With Genital Impact

NCT07444801 | Recruiting

• 2 other identifiers: IIT-ADG-2025IIS-TRALO-2419
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

Hypothesis: Treatment with tralokinumab in patients with moderate-to-severe AD involving the genital region is expected to lead to significant improvements in PROs and clinical disease severity. These improvements will be assessed using genital-specific scoring systems, validated PRO instruments, and non-invasive imaging techniques, including optical coherence tomography (OCT), confocal microscopy, or line-field optical coherence tomography (LC-OCT). Objectives: To investigate improvements in genital scores and PROs in patients with moderate-to-severe AD involving the genital region during treatment with tralokinumab in routine clinical care. Clinical assessment of genital AD severity will be conducted using genital-specific scoring systems (e.g., Genital-Numerical Rating Scale (g-NRS), Genital-Investigator Global Assessment (g-IGA)), validated PRO instruments (e.g., Patient Oriented Eczema Measure (POEM), Atopic Dermatitis Control Tool (ADCT)), and non-invasive imaging techniques (e.g., confocal microscopy, OCT, LC-OCT)

Conditions

Atopic Dermatitis (Moderate-to-severe) Involving the Genital Region

Keywords

atopic dermatits; Moderate-to-Severe Atopic Dermatitis; Genital Atopic Dermatitis; Tralokinumab; Non-Interventional Study

Outcome Measures

Primary Outcomes (1)

• Genital-Numerical Rating Scale

  Improvement of ≥50% in Genital-Numerical Rating Scale (g-NRS) or ≥2 points in Genital-Investigator Global Assessment (g-IGA) in patients with moderate-to-severe AD treated with tralokinumab over a 52-week period.

  52-week period

Study Arms (1)

Patients with moderate-to-severe atopic dermatitis involving the genital region treated with traloki

This cohort includes patients diagnosed with moderate-to-severe atopic dermatitis involving the genital region who are treated with tralokinumab as part of routine clinical care over 52 weeks. Data will be collected at baseline and follow-up visits to assess clinical outcomes and patient-reported measures.

Drug: tralokinumab

Interventions

tralokinumab DRUG

Patients receive tralokinumab as part of routine clinical care according to the licensed product label and physician's clinical decision. The study is observational and does not dictate or assign treatment; it collects data on patients treated with tralokinumab under real-world conditions.

Patients with moderate-to-severe atopic dermatitis involving the genital region treated with traloki

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥18 years) diagnosed with moderate-to-severe atopic dermatitis involving the genital region, who are eligible for systemic therapy with tralokinumab according to the local approved label. Patients are recruited from routine clinical practice at two academic centers and must have signed informed consent prior to any study-related activity.

You may qualify if:

• Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give written, signed and dated informed consent before any study related activity is performed.
• Subjects must be at least 18 years of age at time of enrollment.
• Subjects starting treatment with tralokinumab and for whom the clinical decision has been made independent of the study according to licensed product specifications and treatment guidelines prior to participation in the study.
• Subjects diagnosed with moderate-to-severe AD and genital involvement eligible for systemic therapy according to the local label.

You may not qualify if:

• Subjects incapable of giving full informed consent.
• Current participation in another study with any investigational products (noninterventional or registries are allowed).
• Currently pregnant or nursing women will be excluded from this study.
• Subjects without genital involvement

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead
• LEO Pharma: collaborator

Study Sites (2)

Department of Dermatology of the University Hospital Augsburg

Augsburg, München, 86156, Germany

RECRUITING

CCIM, Institut für Entzündungsmedizin UKSH Lübeck

Lübeck, Schleswig-Holstein, 23538, Germany

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

tralokinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Inga Brouer

CONTACT

+4945150041626; IngaCatharina.Brouer@uksh.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2025
• First Posted: March 3, 2026
• Study Start: October 20, 2025
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: March 3, 2026

Record last verified: 2026-02

Locations

DE (2)